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Biološki lekovi: Tri decenije razvoja

dc.creatorSavić, Miroslav
dc.date.accessioned2019-09-02T11:31:31Z
dc.date.available2019-09-02T11:31:31Z
dc.date.issued2012
dc.identifier.issn0004-1963
dc.identifier.urihttps://farfar.pharmacy.bg.ac.rs/handle/123456789/1807
dc.description.abstractAny medicine whose active substance is present in living organisms, or derived from living organisms, may be considered as a biological product. Vaccines, blood derivatives and products, or hormones isolated from animal or human tissues are produced by traditional biotechnological means and have a long history of use as biologies. With introduction of the recombinant human insulin in 1982, there started an era of 'high-tech' biological medicines, also known as biopharmaceuticals. Recombinant proteins, produced by recombinant DNA technology, and monoclonal antibodies, whose development was based on hybridoma technology, comprise the majority of biopharmaceuticals. The necessity of using biological methods for full characterization is considered by the drug regulation authorities as the key property of biologies, related to complexity and heterogeneity of their structure. Hence, classification of a product as a biological can change over time. For example, the full characterization of antibiotics by physical and chemical methods is feasible nowadays, and hence these drugs are not regarded as biologies any more. Paradoxically, it is possible that a synthetic product be regarded as a biological medicine, and this is the case with pegaptanib, a pegylated modified oligonucleotide, classified into biopharmaceuticals. Hence, the need of introducing a category of borderline products into classification of medicines is noticeable; these products possess some properties of conventional chemical medicines, in addition to those of biologies.en
dc.description.abstractSvaki lek čija je aktivna supstanca nastala u živom organizmu ili je izvedena iz živog organizma može da se smatra biološkim lekom. Vakcine, derivati i proizvodi od krvi ili hormoni izolovani iz tkiva životinja ili čoveka proizvode se tradicionalnim biotehnološkim postupcima i imaju dugu tradiciju primene kao biološki lekovi. Sa uvođenjem rekombinantog humanog insulina, 1982. godine, započela je era „visoko-tehnoloških” bioloških lekova, koji se često označavaju terminom biofarmaceutici. Većinu biofarmaceutika čine rekombinantni proteini, koji se dobijaju tehnologijom rekombinantne DNK, i monoklonska antitela, čiji se razvoj bazirao na hibridoma tehnologiji. Sa regulatornog aspekta, ključna osobina bioloških lekova jeste neophodnost primene bioloških metoda za njihovu punu karakterizaciju, što je posledica kompleksnosti i heterogenosti njihove strukture. Otuda je klasifikacija nekog proizvoda kao biološkog leka podložna promenama. Na primer, danas se antibiotici ne smatraju biološkim lekovima, s obzirom na to da se u potpunosti mogu okarakterisati fizičkim i hemijskim metodama. Paradoksalno, moguće je i da se lek koji se dobija sintezom smatra biološkim lekom i takav je slučaj sa pegaptanibom, pegilovanim modifikovanim oligonukleotidom, koji se klasifikuje kao biofarmaceutik. Otuda, uočava se potreba da se u klasifikaciju uvede i kategorija graničnih proizvoda, koji pored osobina bioloških lekova imaju i osobine konvencionalnih hemijskih lekova.
dc.publisherSavez farmaceutskih udruženja Srbije, Beograd
dc.rightsopenAccess
dc.rights.urihttps://creativecommons.org/licenses/by-sa/4.0/
dc.sourceArhiv za farmaciju
dc.subjectBiological methodsen
dc.subjectBiopharmaceuticalsen
dc.subjectBiotechnological medicinesen
dc.subjectbiofarmaceutici
dc.subjectbiotehnološki lekovi
dc.subjectbiološki metodi
dc.titleBiological medicines: Three decades of progressen
dc.titleBiološki lekovi: Tri decenije razvojasr
dc.typearticle
dc.rights.licenseBY-SA
dcterms.abstractСавић, Мирослав; Биолошки лекови: Три деценије развоја; Биолошки лекови: Три деценије развоја;
dc.citation.volume62
dc.citation.issue4
dc.citation.spage352
dc.citation.epage363
dc.citation.other62(4): 352-363
dc.citation.rankM53
dc.identifier.scopus2-s2.0-84869838492
dc.identifier.fulltexthttp://farfar.pharmacy.bg.ac.rs/bitstream/id/11665/bitstream_11665.pdf
dc.identifier.rcubhttps://hdl.handle.net/21.15107/rcub_farfar_1807
dc.type.versionpublishedVersion


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